Simulation Training for Ultrasound Guided Central Venous Catheter Insertion
27 mars 2020 uppdaterad av: Yale University
Hypothesis #1: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at central venous catheter (CVC) insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by a reduced failure rate at CVC insertion.
Hypothesis #2: Residents who complete a structured, ultrasound guided simulation training protocol will have superior skills at CVC insertion on actual patients as compared to residents who are trained in CVC insertion according to the traditional, bedside apprenticeship model as measured by:
- a reduced number of attempts at venous cannulation,
- a decreased rate of technical errors and a decreased complication rate based on an independent rater's evaluation using a procedure checklist, and
- a decreased time to CVC insertion from opening the catheter kit to placement of sterile dressing as timed by an independent rater.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Resident education has traditionally devoted itself to knowledge acquisition rather than defined levels of clinical competence.
Currently, inexperienced physicians are trained to perform invasive procedures such as central venous catheter (CVC) insertion according to the bedside, apprenticeship model, gaining expertise on real patients in neither a rigorous nor standardized manner.
Simulators may ease trainees' transition to actual patients and avoid adverse events.
This project aims to investigate the efficacy of a structured simulation training protocol in ultrasound guided CVC insertion for resident physicians.
The specific aims are to compare: (1) the failure rate of CVC insertion, and (2) the number of attempts at venous cannulation, rates of technical errors and complications of CVC insertion, and time to CVC insertion on actual patients between residents who completed a structured, hands-on simulation training protocol (intervention group) and those who are trained according to the traditional, bedside apprenticeship model (control group).
We hypothesize that the intervention group will obtain superior skills at CVC insertion on actual patients as compared to the control group as measured by: (1) a reduced failure rate at CVC insertion, (2) a) a reduced number of attempts at venous cannulation b) a decreased rate of technical errors and complications and c) a decreased time to insertion based on an independent rater's evaluation using a procedure checklist.
Studietyp
Observationell
Inskrivning (Faktisk)
184
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06520
- Yale-New Haven Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
PGY-1 or PGY-2 resident status in the Yale-New Haven Hospital Emergency Medicine, Internal Medicine, General Surgery, Obstetric and Gynecology and Anesthesia residency programs.
Beskrivning
Inclusion Criteria:
Eligibility is determined by the program director of the residency programs.
- The racial, gender, and ethnic characteristics of the proposed subject population reflects the demographics of the interns and residents within the specialties of Emergency Medicine, Internal Medicine, General Surgery, Obstetrics and Gynecology and Anesthesia.
- None of the subjects are minors and all are in sufficient health to participate in their residency programs.
Exclusion Criteria:
- Of eligible subjects, the only exclusion criterion is unwillingness to participate in the project.
- No exclusion criteria shall be based on race, gender, or ethnicity.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Control, traditional bedside training
Postgraduate year 1 and 2 residents who are trained in central venous catheter insertion according to the traditional, bedside apprenticeship model.
|
|
|
Simulation training
Postgraduate year 1 and 2 residents who complete a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by: the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous cannulator on a partial task training simulator with no technical errors.
|
Completion of a hands-on ultrasound guided simulation training protocol on a partial task training simulator until competence is achieved as measured by the ability to cannulate a simulated vein under ultrasound guidance on first pass in five consecutive attempts and correct insertion of a central venous catheter on a partial task training simulator with no technical errors.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The failure rate of central venous catheter insertion in the hospital setting on actual patients.
Tidsram: 21 months (January 2007-September 2008)
|
21 months (January 2007-September 2008)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The number of attempts at venous cannulation, and the rate of technical errors and complication rate of central venous catheter insertion in the hospital setting on actual patients
Tidsram: 21 months (January 2007-September 2008)
|
21 months (January 2007-September 2008)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2006
Primärt slutförande (Faktisk)
1 september 2008
Avslutad studie (Faktisk)
1 juni 2009
Studieregistreringsdatum
Först inskickad
9 juni 2009
Först inskickad som uppfyllde QC-kriterierna
11 juni 2009
Första postat (Uppskatta)
12 juni 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 mars 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 mars 2020
Senast verifierad
1 juni 2009
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 0605001388
- 5U18HS016725-02 (U.S.A. AHRQ-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .